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Inspra (Eplerenone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Inspra (Eplerenone) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (68)
Death (3)
Life Threatening Events (3)

Reports by Reaction Type

Renal Failure Acute (9)Dyspnoea (8)Renal Failure (7)Drug Interaction (5)Nausea (5)Hyponatraemia (5)Hypertensive Crisis (5)Dizziness (4)Blood Creatinine Increased (4)Blood Pressure Increased (4)Glomerular Filtration Rate Decreased (4)Blood Potassium Increased (4)

Below are a few examples of reports where side effects / adverse reactions may be related to Inspra (Eplerenone). For a complete list or a specific selection of reports, please use the links above.

Possible Inspra side effects in 79 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-22

Patient: 79 year old male, weighing 66.7 kg (146.7 pounds)

Reactions: Rash Generalised, Skin Exfoliation, Rash Erythematous, DRY Skin

Drug(s) suspected as cause:
Inspra

Other drugs received by patient: Bumetanide; Levothyroxine; Ramipril; Warfarin; Simvastatin



Possible Inspra side effects in 84 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-01

Patient: 84 year old male

Reactions: Aortic Stenosis, Pain, Wound, Orthostatic Hypotension, Tricuspid Valve Calcification, Fall, Aortic Valve Calcification, Malaise, Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eupressyl
    Dosage: 60 mg, 1x/day
    Administration route: Oral
    Start date: 2011-01-01
    End date: 2012-06-08

Inspra
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    Start date: 2011-01-01
    End date: 2012-06-08

Other drugs received by patient: Atorvastatin; Lasix; Perindopril Erbumine; Temerit; Amlodipine Besylate; Plavix; Aspirin



Possible Inspra side effects in 56 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-31

Patient: 56 year old male

Reactions: Long QT Syndrome

Drug(s) suspected as cause:
Bisoprolol Fumarate
    Dosage: oral
    Administration route: Oral

Inspra
    Indication: Product Used FOR Unknown Indication

Procolaran (Ivabradine)
    Indication: Product Used FOR Unknown Indication

Simvastatin
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Inspra side effects in 56 year old male

Reported by a physician from Germany on 2012-07-13

Patient: 56 year old male

Reactions: Long QT Syndrome

Drug(s) suspected as cause:
Bisoprolol Fumarate

Inspra

Ivabradine

Simvastatin



Possible Inspra side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-02

Patient: male

Reactions: Cardio-Respiratory Arrest, Fall, Asthenia, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Inspra
    Dosage: 25 mg, daily
    Administration route: Oral

Revatio
    Dosage: 20 mg, 3x/day
    Administration route: Oral

Other drugs received by patient: Potassium Chloride; Coumadin; Colace; Flovent; Duoneb; Coreg; Mucinex; Multi-Vitamins; Combivent; Mirtazapine; Wellbutrin; Prilosec; Aspirin; Lisinopril; Simvastatin; Ascorbic Acid; Novolog; Prozac; Lantus



Possible Inspra side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-29

Patient: male

Reactions: Cardio-Respiratory Arrest, Asthenia, Fall, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Inspra
    Dosage: 25 mg, daily
    Administration route: Oral

Revatio
    Dosage: 20 mg, 3x/day
    Administration route: Oral

Other drugs received by patient: Prilosec; Coreg; Novolog; Combivent; Wellbutrin; Mirtazapine; Lisinopril; Flovent; Aspirin; Duoneb; Coumadin; Prozac; Multi-Vitamins; Ascorbic Acid; Simvastatin; Colace; Lantus; Potassium Chloride; Mucinex



Possible Inspra side effects in

Reported by a physician from Netherlands on 2012-06-22

Patient:

Reactions: Renal Failure

Drug(s) suspected as cause:
Inspra



Possible Inspra side effects in 70 year old female

Reported by a consumer/non-health professional from Germany on 2012-06-19

Patient: 70 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Inspra
    Dosage: 50 mg, unk
    Indication: COR Pulmonale
    Start date: 2011-01-01

Inspra
    Dosage: 12.5 mg, 1x/day
    Indication: Pleural Effusion



Possible Inspra side effects in 70 year old female

Reported by a consumer/non-health professional from Germany on 2012-06-13

Patient: 70 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Inspra
    Dosage: 12.5 mg, 1x/day
    Indication: Pleural Effusion

Inspra
    Dosage: 50 mg, unk
    Indication: COR Pulmonale
    Start date: 2011-01-01



Possible Inspra side effects in 74 year old male

Reported by a consumer/non-health professional from Venezuela on 2012-06-11

Patient: 74 year old male

Reactions: Dyspnoea, Tracheostomy, Laryngeal Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Inspra



Possible Inspra side effects in 70 year old female

Reported by a consumer/non-health professional from Germany on 2012-06-01

Patient: 70 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: COR Pulmonale, Pleural Effusion

Drug(s) suspected as cause:
Inspra



Possible Inspra side effects in

Reported by a consumer/non-health professional from United States on 2012-05-24

Patient:

Reactions: Renal Disorder

Drug(s) suspected as cause:
Inspra
    Dosage: unk

Norvasc
    Dosage: unk



Possible Inspra side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: male

Reactions: Blood Pressure Increased, Neuropathy Peripheral, Diabetes Mellitus, Headache

Drug(s) suspected as cause:
Inspra



Possible Inspra side effects in

Reported by a consumer/non-health professional from United States on 2012-05-10

Patient:

Reactions: Renal Disorder

Drug(s) suspected as cause:
Inspra
    Dosage: unk

Norvasc
    Dosage: unk



Possible Inspra side effects in male

Reported by a consumer/non-health professional from Canada on 2012-05-04

Patient: male

Reactions: Prostatic Specific Antigen Increased, Drug Intolerance, Cognitive Disorder

Drug(s) suspected as cause:
Inspra
    Dosage: 25 mg, unk
    Indication: Hyperaldosteronism
    Start date: 2011-06-01

Inspra
    Dosage: 12.5 mg, unk
    End date: 2011-10-01

Other drugs received by patient: Vitamin TAB; Androgel; Ginko Biloba



Possible Inspra side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-24

Patient: male

Reactions: Blood Pressure Increased, Diabetes Mellitus

Drug(s) suspected as cause:
Inspra



Possible Inspra side effects in female

Reported by a consumer/non-health professional from NEW Zealand on 2012-04-23

Patient: female

Reactions: Oral Pain, Tongue Disorder, Mouth Ulceration, Oropharyngeal Blistering

Drug(s) suspected as cause:
Inspra



Possible Inspra side effects in female

Reported by a physician from Germany on 2012-04-12

Patient: female, weighing 76.0 kg (167.2 pounds)

Reactions: Aphasia, Thyroid Disorder, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2011-09-27

Digimerck
    Indication: Cardiac Failure

Digimerck
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2006-12-14

Dogmatil
    Dosage: ?-0-? df
    Administration route: Oral
    Indication: Depression
    Start date: 2008-04-21

Inspra
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2005-07-04

Levothyroxine Sodium
    Dosage: 1 df, per day
    Administration route: Oral
    Indication: Thyroid Disorder
    Start date: 2011-09-27

Metformin HCL
    Dosage: 2 df, qd
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-08-23

Metoprolol Tartrate and Hydrochlorothiazide
    Dosage: 0.5 df, bid
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-04-03

Rasilez
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-10-22

Tegretol
    Dosage: 2 df, per day
    Administration route: Oral
    Indication: Depression
    Start date: 2011-09-27

Other drugs received by patient: Diuretics; ACE Inhibitor; HMG COA Reductase Inhibitors; Vasodilators; Calcium Channel Blockers; Nitrates; Antihypertensives



Possible Inspra side effects in female

Reported by a physician from Germany on 2012-04-11

Patient: female, weighing 76.0 kg (167.2 pounds)

Reactions: Type 2 Diabetes Mellitus, Thyroid Disorder, Transient Ischaemic Attack

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Digimerck
    Dosage: 1 df, per day
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2006-12-14

Digimerck
    Indication: Cardiac Failure

Dogmatil
    Dosage: 0.25 df, per day
    Indication: Depression
    Start date: 2008-04-21

Inspra
    Dosage: 1 df, per day
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2005-07-04

Levothyroxine Sodium
    Dosage: 1 df, per day
    Administration route: Oral
    Indication: Thyroid Disorder
    Start date: 2011-09-27

Metformin HCL
    Dosage: 2 df, daily
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2011-08-23

Metoprolol Succinate
    Dosage: 0.5 df, per day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-04-03

Rasilez
    Dosage: 1 df/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-10-22

Other drugs received by patient: Vasodilators Used IN Cardiac Diseases; Calcium Channel Blockers; Nitrates; ACE Inhibitors; Other Antihypertensives; Diuretics



Possible Inspra side effects in female

Reported by a physician from Germany on 2012-04-11

Patient: female, weighing 76.0 kg (167.2 pounds)

Reactions: Aphasia, Thyroid Disorder, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2011-09-27

Digimerck
    Indication: Cardiac Failure

Digimerck
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2006-12-14

Dogmatil
    Dosage: ?-0-? df
    Administration route: Oral
    Indication: Depression
    Start date: 2008-04-21

Inspra
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2005-07-04

Levothyroxine Sodium
    Dosage: 1 df, per day
    Administration route: Oral
    Indication: Thyroid Disorder
    Start date: 2011-09-27

Metformin HCL
    Dosage: 2 df, qd
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-08-23

Metoprolol Tartrate and Hydrochlorothiazide
    Dosage: 0.5 df, bid
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-04-03

Rasilez
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-10-22

Tegretol
    Dosage: 2 df, per day
    Administration route: Oral
    Indication: Depression
    Start date: 2011-09-27

Other drugs received by patient: ACE Inhibitor; Calcium Channel Blockers; Antihypertensives; Vasodilators; Nitrates; HMG COA Reductase Inhibitors; Diuretics



Possible Inspra side effects in male

Reported by a physician from Canada on 2012-04-11

Patient: male

Reactions: Prostatic Specific Antigen Increased, Cognitive Disorder

Drug(s) suspected as cause:
Inspra



Possible Inspra side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-11

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Inspra
    Dosage: unk

Revatio
    Dosage: unk



Possible Inspra side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-10

Patient: male

Reactions: Leukocyturia, Renal Failure Acute

Drug(s) suspected as cause:
Allopurinol
    Dosage: 200 mg
    Administration route: Oral
    Indication: Gout
    Start date: 2010-07-31
    End date: 2010-10-30

Gentamicin Sulfate
    Dosage: 380 mg
    Indication: Staphylococcal Sepsis
    Start date: 2010-10-31
    End date: 2010-11-01

Gentamicin Sulfate
    Dosage: 450 mg
    Start date: 2010-11-02
    End date: 2010-11-04

Inspra
    Dosage: 25 mg
    Administration route: Oral
    Indication: Congestive Cardiomyopathy
    End date: 2010-11-11

Micardis
    Dosage: 80 mg
    Administration route: Oral
    Indication: Congestive Cardiomyopathy
    End date: 2010-11-05

Vancocin Hydrochloride
    Dosage: 750 mg
    Indication: Staphylococcal Sepsis
    Start date: 2010-10-31
    End date: 2010-11-01

Other drugs received by patient: Lasix; Digoxin; Bisoprolol Fumarate



Possible Inspra side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-04

Patient: male

Reactions: Blood Testosterone Decreased, Blood Triglycerides Increased

Drug(s) suspected as cause:
Inspra
    Dosage: unk
    Start date: 2012-01-23

Protonix
    Dosage: unk
    Start date: 2012-01-23



Possible Inspra side effects in 94 year old male

Reported by a physician from Russian Federation on 2012-03-30

Patient: 94 year old male

Reactions: Cardiac Failure Chronic, Dyspnoea, Quality of Life Decreased

Drug(s) suspected as cause:
Inspra
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2011-12-01
    End date: 2012-03-01

Inspra
    Indication: Cardiovascular Insufficiency

Other drugs received by patient: Diuver; Diuver; Metoprolol; Cardiomagnyl; Kardiket; Kardiket; Digoxin; Pradaxa



Possible Inspra side effects in 94 year old male

Reported by a physician from Russian Federation on 2012-03-28

Patient: 94 year old male

Reactions: Dyspnoea, Cardiac Failure Chronic, Quality of Life Decreased

Drug(s) suspected as cause:
Inspra
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2011-12-01
    End date: 2012-03-01

Inspra
    Indication: Cardiovascular Insufficiency

Other drugs received by patient: Cardiomagnyl; Kardiket; Kardiket; Metoprolol; Diuver; Diuver; Pradaxa; Digoxin



Possible Inspra side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-27

Patient: male

Reactions: Weight Increased, Drug Ineffective, Expired Drug Administered

Drug(s) suspected as cause:
Inspra
    Dosage: 25 mg, unk
    Start date: 2012-01-24

Lasix
    Dosage: 30 mg, 1x/day
    Start date: 2012-01-24

Lasix
    Dosage: 100 mg, 1x/day



Possible Inspra side effects in

Reported by a consumer/non-health professional from United States on 2012-03-23

Patient:

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Amiodarone HCL
    Dosage: unk

Amiodarone HCL
    Dosage: unk

Eplerenone
    Dosage: unk

Erythrocin
    Dosage: unk

Erythromycin
    Dosage: unk

Erythromycin Stearate
    Dosage: unk

Inspra
    Dosage: unk



Possible Inspra side effects in male

Reported by a consumer/non-health professional from Canada on 2012-03-22

Patient: male

Reactions: Prostatic Specific Antigen Increased, Drug Intolerance, Cognitive Disorder

Drug(s) suspected as cause:
Inspra
    Dosage: 12.5 mg, unk
    End date: 2011-10-01

Inspra
    Dosage: 25 mg, unk
    Indication: Hyperaldosteronism
    Start date: 2011-06-01



Possible Inspra side effects in 94 year old male

Reported by a physician from Russian Federation on 2012-03-19

Patient: 94 year old male

Reactions: Cardiac Failure Chronic, Dyspnoea, Quality of Life Decreased

Drug(s) suspected as cause:
Inspra
    Indication: Cardiovascular Insufficiency

Inspra
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2011-12-01
    End date: 2012-02-01

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